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The BioMed Alliance has provided recommendations and input to ensure that independent advice is available to regulators responsible for the new EU legislative framework for medical devices and in vitro diagnostics

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04 December 2018

The BioMed Alliance submitted written recommendations, in response to the call for consultation on Scientific bodies under the new EU legislative framework. The new EU Medical Device Regulation 2017/745 (MDR) foresees an independent mechanism of scrutiny of conformity assessment of certain high-risk medical devices (class III and IIb) which is going to be conducted by expert panels. The expert panels will address a range of clinical areas of relevance such as:

Provision of advice in relation to implementation of the EU Medical Device Regulation 2017/745 (MDR), and of the EU In-vitro Diagnostics Regulation 2017/746 (IVDR)